A Phase II Study of CCX282-B in Patients With Celiac Disease

NCT00540657 | Completed Phase 2

• 1 other identifier: CL009_282
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether CCX282-B is effective in mitigating the effects of gluten ingestion in patients with celiac disease

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effect of CCX282-B compared to placebo on the villous height/crypt depth ratio of small intestinal biopsy specimens taken from subjects with celiac disease, before and after gluten exposure.

Secondary Outcomes (3)

• Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure

• Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure

• Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure

Study Arms (2)

1

EXPERIMENTAL

Drug: CCX282-B

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CCX282-B DRUG

250mg capsule, twice daily, 13 weeks

1

Placebo DRUG

Placebo capsule, twice daily, 13 weeks

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, between 18 and 75 years of age
• Established diagnosis of celiac disease
• Subject has been following a strict gluten-free diet for at least 24 months

You may not qualify if:

• History of any infection requiring intravenous antibiotics, a serious local infection, systemic infection, or gastrointestinal infection within 12 weeks of randomization
• Use of any immunosuppressants, TNF inhibitors, or natalizumab during the 12 weeks prior to study randomization
• Use of steroids during the 4 weeks prior to study randomization
• Receipt of an experimental treatment for any disease within 4 weeks prior to randomization
• Known IgE-mediated atopy or allergy or anaphylactic reactions to gluten
• The subject suffers from a condition that carries a risk at endoscopy or is on anticoagulant treatment

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Finn-Medi Research Ltd, Outpatient Clinic

Tampere, FIN-33520, Finland

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

CCX282-B

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

FI (1)